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Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment

This study has been completed.
Sponsor:
Collaborators:
Glaxo Wellcome
Dupont Applied Biosciences
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002419
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1999

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002419 on ClinicalTrials.gov Archive Site
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Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment
A Phase II, 24-Week, Open-Label Study Designed to Evaluate the Safety, Tolerability, and Efficacy of Novel Quadruple-Combination Therapy With Preveon (Adefovir Dipivoxil; Bis-POM PMEA), Abacavir (1592U89), Sustiva (Efavirenz; DMP-266), and Amprenavir (141W94) for the Treatment of HIV-1 Infection in Patients Who Have Failed Previous Protease Inhibitor Treatment

The purpose of this study is to see if it is safe and effective to give adefovir dipivoxil plus abacavir (ABC) plus efavirenz (EFV) plus amprenavir (APV) to HIV-infected patients who have failed to respond to previous treatment with protease inhibitors (PIs).

Patients receive a treatment regimen of adefovir dipivoxil, abacavir, efavirenz, and amprenavir for 24 weeks. During the study, patients are evaluated for changes from baseline in plasma HIV-1 RNA levels and lymphocyte subsets and for development of adverse events and toxicities. Patients who experience virologic failure are discontinued from the study. After Week 24, patients with documented virologic response are eligible to continue receiving the study treatment and to attend scheduled follow-up visits.

Interventional
Phase 2
Endpoint Classification: Safety Study
Primary Purpose: Treatment
HIV Infections
  • Drug: Abacavir sulfate
  • Drug: Amprenavir
  • Drug: Efavirenz
  • Drug: Adefovir dipivoxil
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
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Inclusion Criteria

You may be eligible for this study if you:

  • Are HIV-positive.
  • Had an HIV level of at least 2,000 copies/ml after 6 months of treatment with at least 1 PI other than amprenavir (meaning you failed PI treatment).
  • Are at least 13 years old (need consent of parent or guardian if under 18).
  • Are able to complete the study.
  • Agree to use effective barrier methods of birth control, such as condoms, during the study.

Exclusion Criteria

You will not be eligible for this study if you:

  • Have certain serious medical conditions, including AIDS-related cancers (except Kaposi's sarcoma) that require treatment during the study.
  • Have ever taken or are allergic to adefovir dipivoxil, ABC, APV, EFV.
  • Are participating in another anti-HIV drug trial during this study.
  • Have taken certain medications within 30 days prior to study entry, including medications that affect your immune system.
  • Have been diagnosed with hepatitis within the past 30 days.
  • Abuse alcohol or drugs.
  • Are pregnant or breast-feeding.
  • Have ever taken NNRTIs.
  • Have ever taken ddI or d4T.
  • Have received chemotherapy or radiation therapy within 30 days prior to study entry.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002419
299A, ICC 605
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Gilead Sciences
  • Glaxo Wellcome
  • Dupont Applied Biosciences
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NIH AIDS Clinical Trials Information Service
November 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP